Nature's Sunshine NutriSmart Mezcla en polvo a base de proteina de soya enriquecida con…
Pro-Form Manufacturing LLC recalled this product and the FDA reported the enforcement action on 4 March 2020 as Class III. The recall was initiated by the firm. Notified by supplier that flax seed used in products is under recall due to detection of unapproved herbicide.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Nature's Sunshine NutriSmart Mezcla en polvo a base de proteina de soya enriquecida con vitaminas y minerals; Vainilla Plastic HDPE jar Contenido Neto 510 g UPC: 0 80030910217 Product number: 6116-GE3091 Elaborado por: Nature's Sunshine Products Inc. 1655 North Main Spanish Fork, UT 84660
- UPC
- 080030910217
- Reason for recall
- Notified by supplier that flax seed used in products is under recall due to detection of unapproved herbicide.
- Recalling firm
- Pro-Form Manufacturing LLC
- Firm location
- Benicia, California, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-0781-2020
- Quantity
- 4091 units
- Distribution
- UT, MN. Some product was further distributed to Columbia, Mexico, Russia and Ukraine.
- Initiated
- 19 February 2020
- Reported by FDA
- 4 March 2020
- Terminated
- 21 March 2022
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot Number: 19336-41
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This is one of 7 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 7 separate recalls, which almost every published figure does, overstates it by a factor of 7. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 7 of them.
- The recall ran for 2.1 years, from 19 February 2020 to termination on 21 March 2022. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The distribution pattern names 1 state, and the FDA published the enforcement report 2 weeks after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was longer than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
What this recall was for
Chemical contamination
A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.
A preventive controls plan covers chemical contamination under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.35(b)
- Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
- 21 CFR 117.130(b)(1)(ii)
- Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.
Unapproved ingredients
An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.
A preventive controls plan covers an unapproved ingredient under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 111
- Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
Filed under dietary supplements. A product can sit in more than one.
Other dietary supplements recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Pro-Form Manufacturing LLC
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 6 other records name this firm.
All 7 records for Pro-Form Manufacturing LLC
All 2020 recalls · All FDA food recall data
21 CFR 117.35(b) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.